Proposals to Amend the New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standards...

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Proposals to Amend the New Zealand

(Maximum Residue Limits of Agricultural

Compounds) Food Standards 2008

NZFSA Public Discussion Paper 01/08

30 May 2008

Online

ISBN number 978-0-478-32207-1

ISSN number 1177-7478

Print

ISBN number 978-0-478-32206-4

ISSN number 1174-961X


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Proposals to Amend the New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standards 2008

IMPORTANTDISCLAIMER

Every effort has been made to ensure the information in this report is accurate.

NZFSA does not accept any responsibility or liability whatsoever for any error of fact, omission,interpretation or opinion that may be present, however it may have occurred.

Further copies

Requests for further copies should be directed to:

New Zealand Food Safety Authority

P O Box 2835

WELLINGTON

Telephone: (04) 894-2500

Fax: (04) 894-2583

Website

A copy of this document can be found at: http://www.nzfsa.govt.nz/policy-law/consultation/index.htm


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Submissions

NZFSA seeks submissions from all interested parties on any aspect of the document. The

following points may be of assistance in preparing comments:

Wherever possible, comment should be specific to a particular section in the document. All

major sections are numbered and these numbers should be used to link comments to the

document.

Omissions should be clearly and separately indicated.

Comments should be to the point and, where possible, reasons and data to support

comment are requested.

The use of examples to illustrate particular points is encouraged.

As a number of copies may be made of your comments, please use good quality type, pr

make sure the comments are clearly had-written in black or blue ink.

Please include the following information in your submission:

The title of the discussion document;

Your name and title (if applicable);

Your organisations name (if applicable);

Your address;

The number(s) of the sections you are commenting on.

Please submit your response by 5:00pm on Wednesday 30th

July 2008 to:

MRL Amendments, Policy Group, New Zealand Food Safety Authority

PO Box 2835, Wellington, fax: (04) 894 2583, or email: [email protected]

The Official Information Act 1982 (the OIA) states that information is to be made available

unless there are grounds for withholding it. The grounds for withholding information are outlined

in the OIA. Submitters may wish to indicate any grounds for withholding information contained

in their submission. Reasons for withholding information could include that information is

commercially sensitive or that the submitters wish personal information such as names or

contact details to be withheld. NZFSA will take such indications into account when determining

whether or not to release information. Any decision to withhold information requested under the

OIA may be reviewed by the Ombudsman.


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Table of Contents

Table of Contents.................................................................................................... 3

Introduction............................................................................................................. 4

Background............................................................................................................. 4

Summary of Proposed Amendment...................................................................... 6

Next Steps ............................................................................................................... 7

1 Proposal to set an MRL for Chloramphenicol ........................................... 8

2 Proposal to set an MRL for Chlorantraniliprole ...................................... 10

3 Proposal to set an MRL for Cymoxanil .................................................... 12

4 Proposal to set an MRL for Cyprodinil..................................................... 14

5 Proposal to set an MRL for Fludioxinil..................................................... 16

6 Proposal to set an MRL for Formetanate Hydrochloride ....................... 18

7 Proposal to set an MRL for Lincomycin................................................... 20

8 Proposal set an MRL for Myclobutanil..................................................... 22

9 Proposal to set an MRL for Neomycin ..................................................... 24

10 Proposal to set an MRL for Spinosad ...................................................... 27

11 Proposal to exempt Chlorhexidine ........................................................... 30


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Introduction

The New Zealand Food Safety Authority (NZFSA) invites public comment on this discussion

document which outlines proposals to amend the New Zealand (Maximum Residue Limits of

Agricultural Compounds) Food Standards 2008.

Maximum residue limits (MRLs) are the maximum legal limits for residues of agricultural

compounds and veterinary medicines in food for sale in New Zealand.

MRLs are primarily a tool for monitoring the use of agricultural compounds in accordance with

good agricultural practice (GAP). GAP is not explicitly defined or regulated, but is the generally

accepted means for producing safe primary produce in a particular location while taking accountof climate, pests or diseases and other environmental factors.

MRLs are used to minimise risks to public health by ensuring that chemical residues in food are

as low as practicable, without compromising the ability of the chemical to successfully do what

is intended.

Background

MRLs are set out in the New Zealand (Maximum Residue Limits of Agricultural Compounds)

Food Standards. The Standards are amended a number of times each year to reflect changes

in the use of agricultural compounds in the production of food. The current MRL Food

Standards 2008 are on the NZFSA website at: http://www.nzfsa.govt.nz/policy-

law/legislation/food-standards/index.htm

NZFSA administers the MRL Standards, but the final decision on any changes to the Standards

rests with the Minister for Food Safety. Under section 11E of the Food Act, when amending or

issuing the MRL Standards, the Minister must take into account the following:

the need to protect public health

the desirability of avoiding unnecessary restrictions on trade

the desirability of maintaining consistency between New Zealand's food standards and

those applying internationally

New Zealand's obligations under any relevant international treaty, agreement, convention,

or protocol, and, in particular, under the Australia-New Zealand Joint Food Standards

Agreement

such other matters as the Minister considers appropriate.


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The proposed MRLs have been thoroughly assessed in accordance with international

methodologies such as those utilised by the expert committees advising the Codex Alimentarius

Commission (Codex). Information on the technical assessment of each proposal is included in

this document and covers the following:

rationale

chemical information

good agricultural practice (GAP)

residues information

dietary risk assessment

toxicological / public health assessment

international MRLs.

Possible implications for public health are considered during the toxicological and dietary risk

assessments, by comparing the estimated dietary intake with a Potential Daily Exposure (food)

(PDEfood) or where there is no PDEfood, by comparing it with the Acceptable Daily Intake (ADI).

PDEfood and ADI are described below.

A PDEfood or Potential Daily Exposure (food), is a value determined by a toxicological evaluation

by Environmental Risk Management Authority New Zealand (ERMA NZ) as part of its

responsibilities under the Hazardous Substances and New Organisms Act (the HSNO Act),

which has some responsibility for managing public health.1

A PDEfood gives the potential daily

exposure a person may be subject to from a substance, via food. NZFSA uses a PDEfood, rather

than the internationally-determined ADI, where a PDEfood is available, due to the HSNO Act in

New Zealand. The ADI and PDEfood are largely equivalent, as they are determined using the

same set of toxicology data and in a very similar scientific process.

An ADI or Acceptable Daily Intake is defined by the World Health Organization (WHO) as: The

daily intake which, during an entire lifetime, appears to be without appreciable risk on the basis

of all the known facts at the time. Without appreciable risk has been further defined as: the

practical certainty that injury will not result even after a lifetime of exposure. ADIs are

established by the WHO and Food and Agriculture Organization of the United Nations (FAO)

joint expert committees, made up of toxicologists and residue specialists. The ADI information

from these joint committees also feeds into the Codex Alimentarius Commission (Codex), which

sets international MRLs.


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NZFSA has reviewed the estimated dietary exposure assessments for the applications of these

proposals and has determined that the residues associated with the proposed MRLs do not present

any public health and safety concerns.

Summary of Proposed Amendment

New MRLs

NZFSA proposes to add the following new MRLs to the Standards:

0.0003mg/kg for chloramphenicol in any food

0.3mg/kg for chlorantraniliprole in brassica vegetables and pomefruit;

0.05mg/kg for cymoxanil in garlic, onions and potatoes;

1mg/kg for cyprodinil in strawberries;

1mg/kg for fludioxinil in strawberries;

0.2mg/kg for formetanate hydrochloride in onions;

0.15mg/kg for lincomycin in cattle milk;

0.02mg/kg for myclobutanil in cucurbits (inedible peel);

1.5mg/kg for neomycin in cattle milk as a replacement for 0.5mg/kg for neomycin in cattle

milk; and

0.05mg/kg for spinosad in tomatoes as a replacement for 0.01mg/kg for spinosad in

tomatoes.

New MRL Exemptions

NZFSA proposes to add the following MRL exemption to the Standards:

Chlorhexidine and its digluconate salt when applied as a topical antiseptic to all food

producing species except fish.

1The purpose of the HSNO Act 1996 is to protect the environment, and the health and safety of people and communities, bypreventing or managing the adverse effects of hazardous substances and new organisms.


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Next Steps

Following the closing date for submissions (5:00pm on Wednesday 30 th July 2008), all

submissions will be considered and analysed before a recommendation is made to the Minister

for Food Safety, the Hon Lianne Dalziel, who makes the final decision on issuing any

amendments to the Food Standards.

If an amendment is agreed upon, it will be signed by the Minister for Food Safety and will come

into force 28 days after being published in the New Zealand Gazette.


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1 Proposal to set an MRL for Chloramphenicol

It is proposed that an MRL is set for chloramphenicol when occurring as a veterinary medicine in all

food products. It is proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended

to include the following; this will be the resulting entry for chloramphenicol in Schedule One of the NZ

(MRL) Food Standards 2008:

Compound CAS# Residue definition FoodMaximum ResidueLimit (mg/kg)

Chloramphenicol 56-75-7

Sum of:chloramphenicol and

chloramphenicolglucuronideExpressed as:chloramphenicol

Any food0.0003*

NOTE: (*) indicates that the maximum residue limit has been set at or about the limit of analytical

quantification.

Amendment Rationale

The proposed MRL for chloramphenicol represents that is unacceptable for chloramphenicol to be

used in veterinary medicine in New Zealand or to be detectable in any food products. This MRL will

apply to all food products imported into, or produced in, New Zealand.

Chemical Information

Common name of compound ChloramphenicolUse of compound AntibioticChemical Abstract Services (CAS) Registry number 56-75-7Type of compound PhenicolAdministration method n/a

Good Agricultural Practice

Chloramphenicol is not registered for use or used in New Zealand and is widely banned or restricted

overseas. Given this status it is unacceptable that it is used for any purpose leading to residues in

food in New Zealand.

Residues Information

The proposed MRL is at the limit of analytical quantification. Therefore, the MRL represents that no

detectable residues of chloramphenicol should occur in any food products.


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Dietary Risk Assessment

As residues of chloramphenicol are proposed to be regulated to the limit of analytical quantification in

all food products, the proposal is not expected to result in any dietary risk.

Toxicological / Public Health Assessment

It has been determined that the use of chloramphenicol in the veterinary treatment of food producing

animal species is unacceptable. Therefore, regulating that no detectable residues shall occur in food

products will ensure that there is no risk to public health.

Other International MRLs

Compound FoodMaximum Residue Limit(mg/kg)

CanadaChloramphenicol All foods BannedEuropean UnionChloramphenicol All foods Banned

Note that in the European Community, a Minimum Required Performance Limit (MRPL) of

0.0003mg/kg is required for testing laboratories. This level is set at the content of an analyte which

can be detected and confirmed by official laboratories in the European Union. The MRPL is set to

ensure harmonised implementation of the controls to certify the absence of chloramphenicol in the

consignments.

To meet New Zealands obligations under the Agreement on the Application of Sanitary and

Phytosanitary Measures the proposed MRL will be notified to the World Trade Organization. Any

country may choose to comment if they believe the proposed MRL represents a barrier to their trade.


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2 Proposal to set an MRL for Chlorantraniliprole

It is proposed that an MRL is set for chlorantraniliprole when used as an insecticide for brassica

vegetables and pome fruits. It is proposed that Schedule One of the NZ (MRL) Food Standards 2008

be amended to include the following; this will be the resulting entry for chlorantraniliprole in Schedule

One of the NZ (MRL) Food Standards 2008:


Chlorantraniliprole 500008-45-7 ChlorantraniliproleBrassicavegetables

Pome fruit

0.3

0.3

Amendment Rationale

The proposed MRL for chlorantraniliprole represents the registration in New Zealand of a new active

ingredient. The proposed MRL will manage the use of chlorantraniliprole as an insecticide on brassica

vegetable and pome fruits to the application rates and withholding periods that are approved good

agricultural practice (GAP) in New Zealand (see below).


Common name of compound ChlorantraniliproleUse of compound InsecticideChemical Abstract Services (CAS) Registry number 500008-45-7Type of compound DiamideAdministration method Spray


Chlorantraniliprole is proposed for use as an insecticide for brassica vegetables. Application may be 3

times per season as pests appear, at 20gai/ha with a withholding period of 7 days.

Chlorantraniliprole is also proposed for use as an insecticide for pome fruits. Application may be 3

times per season from petal fall, at 63gai/ha with a withholding period of 14 days.


Residue data for chlorantraniliprole in brassica vegetables supports an MRL of 0.3mg/kg at 7 days

after the last treatment. An MRL of 0.3mg/kg is therefore proposed to support GAP.

Residue data for chlorantraniliprole in pome fruits supports an MRL of 0.3mg/kg at 14 days after the

last treatment. An MRL of 0.3mg/kg is therefore proposed to support GAP.


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Animal Transfer

Residue transfer to animals grazing treated orchards has not been assessed as it is not acceptablepractice that treated orchards be grazed. Animals may consume treated brassica vegetables,

however it is not expected that residues will result in any animal derived food products. Animal

derived food product limits are therefore not proposed.


Acceptable Daily Intake (ADI) 1.58mg/kg bw/day

The potential daily exposure via food (PDE(food)) is used for dietary intake calculation where a value

has been set. An appropriate acceptable daily intake (ADI) is used in the absence of a PDE(food).

The chronic dietary exposure to chlorantraniliprole is estimated by the National Estimated Dietary

Intake (NEDI) calculation encompassing all registered uses of the chemical and food consumption

data based upon the 1997 National Nutritional Survey for adults and the 1995 National Nutrition

Survey of Australia, for children. The NEDI calculation is made in accordance with Guidelines for

predicting dietary intake of pesticide residues (revised) [World Health Organisation, 1997].

The NEDI for chlorantraniliprole is equivalent to 0.03% of the ADI. It is therefore concluded that the

chronic dietary exposure is small and the risk is acceptable.


It has been determined that the use of chlorantraniliprole as an insecticide for use on brassica

vegetables and pome fruits, according to GAP specified above, is very unlikely to pose any health

risks from consumption of the harvested commodities.



Phytosanitary Measures the proposed MRLs will be notified to the World Trade Organization. Any

country may choose to comment if they believe the proposed MRLs represent a barrier to their trade.


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3 Proposal to set an MRL for Cymoxanil

It is proposed that an MRL is set for cymoxanil when used as a fungicide for garlic, onions and

potatoes. It is proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended to

include the following entries:


Cymoxanil 57966-95-7 CymoxanilGarlicOnionsPotatoes

0.05*0.05*0.05*

NOTE: (*) indicates that the maximum residue limit has been set at or about the limit of analyticalquantification.

The final entry for cymoxanil in Schedule One of the NZ (MRL) Food Standards 2008 will therefore

read:


Cymoxanil 57966-95-7 Cymoxanil

GarlicOnionsPeas

Potatoes

0.05*0.05*0.05*

0.05*NOTE: (*) indicates that the maximum residue limit has been set at or about the limit of analytical

quantification.

Amendment Rationale

The proposed MRLs represent new use patterns in New Zealand of cymoxanil as a fungicide on garlic,

onions and potatoes to the application rates and withholding periods that are approved good



Common name of compound CymoxanilUse of compound FungicideChemical Abstract Services (CAS) Registry number 57966-95-7Type of compound Aliphatic nitrogenAdministration method Spray


Cymoxanil is proposed for use as a fungicide for garlic, potatoes and onions. Application may be

throughout plant growth, at 0.09 - 0.165kgai/ha with a withholding period of 14 days.


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Residue data for garlic, onions and potatoes support limit of quantification MRLs of 0.05mg/kg at 14

days after the last treatment. MRLs of 0.05mg/kg are therefore proposed to support GAP.

Animal Transfer

Animals may be fed failed crops of onions and potatoes. Given that no residues are expected in

treated crops, it is concluded that there is not likely to be any animal transfer of residues. Animal






The chronic dietary exposure to cymoxanil is estimated by the National Estimated Dietary Intake

(NEDI) calculation encompassing all registered uses of the chemical and food consumption data

based upon the 1997 National Nutritional Survey for adults and the 1995 National Nutrition Survey of

Australia, for children. The NEDI calculation is made in accordance with Guidelines for predicting

dietary intake of pesticide residues (revised) [World Health Organisation, 1997].

The NEDI for cymoxanil is equivalent to 0.5% of the ADI. It is therefore concluded that the chronic

dietary exposure is small and the risk is acceptable.


It has been determined that the use of cymoxanil as a fungicide for use on garlic, onions and potatoes,

according to the GAP specified above, is very unlikely to pose any health risks from consumption of

the harvested commodities.



The NetherlandsCymoxanil All foods 0.05*


Phytosanitary Measures the proposed MRLs will be notified to the World Trade Organization. Any

country may choose to comment if they believe the proposed MRLs represent a barrier to their trade.


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4 Proposal to set an MRL for Cyprodinil

It is proposed that an MRL is set for cyprodinil when used as a fungicide for strawberries. It is

proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended to include the

following entry:


Cyprodinil 121552-61-2 Cyprodinil Strawberries 1

The final entry for cyprodinil in Schedule One of the NZ (MRL) Food Standards 2008 will therefore

read:


Cyprodinil 121552-61-2 Cyprodinil

GrapesNectarinesPeachesPomefruitsStrawberries

0.20.020.020.011

Amendment Rationale

The proposed MRL represents a new use pattern in New Zealand for the active ingredient cyprodinil.

The proposed MRL will manage the new use of cyprodinil as a fungicide on strawberries to the

application rates and withholding periods that are approved good agricultural practice (GAP) in New

Zealand (see below).


Common name of compound CyprodinilUse of compound FungicideChemical Abstract Services (CAS) Registry number 121552-61-2

Type of compound PyrimidineAdministration method Spray


Cyprodinil is proposed for use as a fungicide for strawberries. Application may be 2-3 times at 7-14

day intervals after flowering, at 300gai/ha with a withholding period of 3 days.


Residue data for strawberries support an MRL of 1mg/kg at 3 days after the last treatment. An MRL of

1mg/kg is therefore proposed to support GAP.


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Animal Transfer

Strawberries are not considered an animal feed commodity. Animal derived food product limits aretherefore not proposed.





The chronic dietary exposure to cyprodinil is estimated by the National Estimated Dietary Intake





The NEDI for cyprodinil is equivalent to 0.3% of the ADI. It is therefore concluded that the chronic



It has been determined that the use of cyprodinil as a fungicide for use on strawberries, according to

the GAP specified above, is very unlikely to pose any health risks from consumption of the harvested

commodity.



The NetherlandsCyprodinil Strawberries 2





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5 Proposal to set an MRL for Fludioxinil

It is proposed that an MRL is set for fludioxinil when used as a fungicide for strawberries. It is


following entry:


Fludioxinil 131341-86-1 Fludioxinil Strawberries 1

The final entry for fludioxinil in Schedule One of the NZ (MRL) Food Standards 2008 will therefore

read:


Fludioxinil 131341-86-1 FludioxinilGrapesStrawberries

0.051

Amendment Rationale

The proposed MRL represents a new use pattern in New Zealand for the active ingredient fludioxinil.

The proposed MRL will manage the new use of fludioxinil as a fungicide on strawberries to the




Common name of compound FludioxinilUse of compound FungicideChemical Abstract Services (CAS) Registry number 131341-86-1Type of compound PyrimidineAdministration method Spray


Fludioxinil is proposed for use as a fungicide for strawberries. Application may be 2-3 times at 7-14

day intervals after flowering, at 200gai/ha with a withholding period of 3 days.


Residue data for strawberries support an MRL of 1mg/kg at 3 days after the last treatment. An MRL of

1mg/kg is therefore proposed to support GAP.


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Animal Transfer

Strawberries are not considered an animal feed commodity. Animal derived food product limits aretherefore not proposed.





The chronic dietary exposure to fludioxinil is estimated by the National Estimated Dietary Intake





The NEDI for fludioxinil is equivalent to 0.8% of the ADI. It is therefore concluded that the chronic



It has been determined that the use of fludioxinil as a fungicide for use on strawberries, according to


commodity.



The NetherlandsFludioxinil Strawberries 2





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6 Proposal to set an MRL for Formetanate

Hydrochloride

It is proposed that an MRL is set for formetanate hydrochloride when used as an insecticide for

onions. It is proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended to

include the following; this will be the resulting entry for formetanate hydrochloride in Schedule One of

the NZ (MRL) Food Standards 2008:

Compound CAS# Residue definition Food

Maximum

Residue Limit(mg/kg)

Formetanatehydrochloride

23422-53-9 Formetanate free base Onions 0.2

Amendment Rationale

The proposed MRL for formetanate hydrochloride represents the registration in New Zealand of a new

active ingredient. The proposed MRL will manage the new use of formetanate hydrochloride as an

insecticide on onions to the application rates and withholding periods that are approved good



Common name of compound Formetanate hydrochlorideUse of compound InsecticideChemical Abstract Services (CAS) Registry number 23422-53-9Type of compound N-methyl carbamateAdministration method Spray


Formetanate hydrochloride is proposed for use as an insecticide for onions. Application may be on

mature crops, at 0.75kgai/ha with a withholding period of 14 days.


Residue data for onions support an MRL of 0.2mg/kg at 14 days after the last treatment. An MRL of

0.2mg/kg is therefore proposed to support GAP.


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Animal Transfer

Onions are not a primary animal feed crop. It is conceivable that failed crops may be fed to animals;however it is unlikely that detectable residues will arise in animal derived food products. Animal






The chronic dietary exposure to formetanate hydrochloride is estimated by the National Estimated

Dietary Intake (NEDI) calculation encompassing all registered uses of the chemical and food

consumption data based upon the 1997 National Nutritional Survey for adults and the 1995 National

Nutrition Survey of Australia, for children. The NEDI calculation is made in accordance with Guidelines

for predicting dietary intake of pesticide residues (revised) [World Health Organisation, 1997].

The NEDI for formetanate hydrochloride is equivalent to 2% of the ADI/PDE(food). It is therefore

concluded that the chronic dietary exposure is small and the risk is acceptable.


It has been determined that the use of formetanate hydrochloride as an insecticide for use on onions,


the harvested commodity.



The NetherlandsFormetanate All foods 0.05*


quantification.





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7 Proposal to set an MRL for Lincomycin

It is proposed that an MRL is set for lincomycin when used as a veterinary medicine for cattle. It is


following; this will be the resulting entry for lincomycin in Schedule One of the NZ (MRL) Food

Standards 2008:


Lincomycin 154-21-2 Lincomycin Cattle milk 0.15

Amendment Rationale

The proposed MRL represents the setting of a New Zealand MRL for lincomycin in cattle milk that will

be harmonised with MRLs set internationally by the European Union and by the Codex Alimentarius

Commission.

It is intended that the increase in the MRL will allow the milking withholding period to be decreased

allowing a greater flexibility in the use of lincomycin in the treatment of mastitis


Common name of compound LincomycinUse of compound AntibioticChemical Abstract Services (CAS) Registry number 154-21-2Type of compound LincosamideAdministration method Intramammary


Lincomycin is currently approved in New Zealand as an antibiotic treatment for mastitis in cattle by

way of intramammary, with a withholding period of 3 days for milk and 30 days for meat.


The proposed MRL has been determined by Codex to represent a suitable international standard for

residues.



The potential daily exposure via food (PDE(food))is used for dietary intake calculation where a value hasbeen set. An appropriate acceptable daily intake (ADI) is used in the absence of a PDE(food).


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The chronic dietary exposure to lincomycin is estimated by the National Estimated Dietary Intake





The NEDI for lincomycin is equivalent to 3% of the ADI. It is therefore concluded that the chronic



Promulgation of the proposed MRL for lincomycin as an antibiotic treatment for mastitis in cattle is very

unlikely to pose any health risks from consumption of the milk from treated cattle.



CodexLincomycin Cattle Milk 0.15European UnionLincomycin Milk 0.15Japan

Lincomycin Milk 0.15 (Provisional)





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8 Proposal set an MRL for Myclobutanil

It is proposed that an MRL is set for myclobutanil when used as a fungicide for cucurbits. It is


following entry:


Myclobutanil 88671-89-0 MyclobutanilCucurbits(inediblepeel)

0.02

The final entry for myclobutanil in Schedule One of the NZ (MRL) Food Standards 2008 will therefore

read:


Myclobutanil 88671-89-0 Myclobutanil

Cucurbits(inediblepeel)GrapesPome fruits

0.020.20.1

Amendment Rationale

The proposed MRL represents a new use pattern in New Zealand for myclobutanil. The proposed

MRL will manage the new use of myclobutanil as a fungicide on cucurbits (inedible peel) to the




Common name of compound Myclobutanil

Use of compound FungicideChemical Abstract Services (CAS) Registry number 88671-89-0Type of compound ConazoleAdministration method Spray


Myclobutanil is proposed for use as a fungicide for cucurbits (inedible peel). Application may be up to

2 times at 10-14 day intervals, at 75gai/ha with a withholding period of 7 days.


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Residue data for cucurbits (inedible peel) support an MRL of 0.02mg/kg at 7 days after the last

treatment. An MRL of 0.02mg/kg is therefore proposed to support GAP.

Animal Transfer

It is not expected that residues will result in any animal derived food products. Animal derived food

product limits are therefore not proposed.





The chronic dietary exposure to myclobutanil is estimated by the National Estimated Dietary Intake





The NEDI for myclobutanil is equivalent to 0.77% of the ADI. It is therefore concluded that the chronic



It has been determined that the use of myclobutanil as a fungicide for use on cucurbits (inedible peel),


the harvested commodity.



The NetherlandsMyclobutanil Pumpkin 0.2





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9 Proposal to set an MRL for Neomycin

It is proposed that an MRL is set for neomycin when used as a veterinary medicine for cattle. It is

proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended by deleting the

following entry:


Neomycin 1404-04-2 Neomycin Cattle milk 0.5

As a replacement for the deleted entry, it is proposed that Schedule One of the NZ (MRL) Food

Standards 2008 be amended to include the following entry:


Neomycin 1404-04-2 Neomycin Cattle milk 1.5

The final entry for Neomycin in Schedule One of the NZ (MRL) Food Standards 2008 will therefore

read:


Neomycin 1404-04-2 Neomycin

Cattle milkMammalianfatMammaliankidneyMammalianliverMammalianmeatPoultry eggsPoultry fatPoultry liverPoultry meat

1.5

0.5

5

0.5

0.50.50.50.50.5

Amendment Rationale

The proposed MRL represents the setting of a New Zealand MRL for neomycin in cattle milk that will

be harmonised with MRLs set internationally by Australia, the European Union and by the Codex

Alimentarius Commission.

It is intended that the increase in the MRL will allow the milking withholding period to be decreased

allowing a greater flexibility in the use of neomycin in the treatment of bacterial infections and mastitis


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Common name of compound NeomycinUse of compound AntibioticChemical Abstract Services (CAS) Registry number 1404-04-2Type of compound AminoglycosideAdministration method Intramammary or injection


Neomycin is currently approved in New Zealand as an antibiotic treatment for bacterial infections and

mastitis in cattle way of intramammary or injection, with withholding periods ranging from 3-5days for

milk and 30-35 days for meat.


The proposed MRL has been determined by Codex to represent a suitable international standard for

residues.



The potential daily exposure via food (PDE(food))is used for dietary intake calculation where a value has

been set. An appropriate acceptable daily intake (ADI) is used in the absence of a PDE(food).

The chronic dietary exposure to neomycin is estimated by the National Estimated Dietary Intake





The NEDI for neomycin is equivalent to 15% of the ADI. It is therefore concluded that the chronic



Promulgation of the proposed MRL for neomycin as an antibiotic treatment for bacterial infections and

mastitis in cattle is very unlikely to pose any health risks from consumption of milk from treated cattle.


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Compound Food Maximum Residue Limit(mg/kg)

CodexNeomycin Cattle Milk 1.5European UnionNeomycin Milk 1.5AustraliaNeomycin Milk 1.5 (Temporary)





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10 Proposal to set an MRL for Spinosad

It is proposed that an MRL is set for spinosad when used as an insecticide for Tomatoes. It is

proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended by deleting the

following entry:


Spinosad

168316-95-8(131929-60-7+

131929-63-0)

Sum of:spinosyn Aspinosyn D

Expressed as:Spinosad

Tomatoes 0.01*


quantification.

As a replacement for the deleted entry, it is proposed that Schedule One of the NZ (MRL) Food

Standards 2008 be amended to include the following entry:


Spinosad

168316-95-8

(131929-60-7+131929-63-0)

Sum of:

spinosyn Aspinosyn DExpressed as:Spinosad

Tomatoes 0.05

The final entry for spinosad in Schedule One of the NZ (MRL) Food Standards 2008 will therefore

read:


Spinosad

168316-95-8(131929-60-7+131929-63-0)

Sum of:spinosyn Aspinosyn DExpressed as:Spinosad

Citrus fruitsKiwifruit

PotatoesSheep fatSheep kidneySheep liverSheep meatStone fruitsTomatoes

0.050.2

0.01(*)0.20.050.050.0510.05


quantification.

Amendment Rationale

The proposed MRL represents a change in good agricultural practice (GAP) for the active ingredient

spinosad.


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The MRL proposed for spinosad in tomatoes will allow the compound to be used closer to harvest in

accordance with the specified GAP in New Zealand (see below) based on a new application method

and formulation type. As spinosad is considered to be of very low toxicity, there is no risk to public

health associated with consumption of tomatoes containing spinosad residues within the MRL.

Spinosad is used internationally and is considered as a risk reducing compound relative to older

chemistries. Spinosad has been specifically attributed risk reducing status in Canada and the United

States. As spinosad is naturally derived from bacteria, it has been permitted for use in organic

production by the United States Department of Agriculture.


Common name of compound SpinosadUse of compound InsecticideChemical Abstract Services (CAS) Registry number 500008-45-7Type of compound SpinosynAdministration method Ground spray and dustable powder


Spinosad is proposed for use as an insecticide for tomatoes. Application may be up to 7 times

throughout plant growth at a rate of 10-20g per mature plant with a withholding period of 3 days.


Residue data for tomatoes support an MRL of 0.05mg/kg at 3 days after the last treatment. An MRL

of 0.05mg/kg is therefore proposed to support GAP.





The chronic dietary exposure to spinosad is estimated by the National Estimated Dietary Intake (NEDI)

calculation encompassing all registered uses of the chemical and food consumption data based upon

the 1997 National Nutritional Survey for adults and the 1995 National Nutrition Survey of Australia, for

children. The NEDI calculation is made in accordance with Guidelines for predicting dietary intake of

pesticide residues (revised) [World Health Organisation, 1997].

The NEDI for spinosad is equivalent to 3.5% of the ADI. It is therefore concluded that the chronic



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It has been determined that the use of spinosad as an insecticide for use on tomatoes, according to


commodity.






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11 Proposal to exempt Chlorhexidine

It is proposed that an MRL exemption is set for chlorhexidine when used as a topical antiseptic for all

food producing species except fish. It is proposed that Schedule Three of the NZ (MRL) Food

Standards 2008 be amended to include the following; this will be the resulting entry for chlorhexidine

in Schedule Three of the NZ (MRL) Food Standards 2008:

Compound CAS# Condition

Chlorhexidine and itsdigluconate salt

55-56-1All food producing species except fish; for topical useonly

Amendment Rationale

The proposed MRL exemption represents a reassessment of a currently approved use patterns for

chlorhexidine, which has a very low toxicity. Chlorhexidine is commonly used in human medicine, and

following the treatment of food producing species with chlorhexidine, any levels of residues likely to

exist are insignificant. For these reasons chlorhexidine residues do not require a regulatory limit.

Chlorhexidine can therefore be exempted from the requirement of a New Zealand MRL.


Common name of compound ChlorhexidineUse of compound Topical antiseptic and disinfectantChemical Abstract Services (CAS) Registry number 55-56-1Type of compound Bis-biguanideAdministration method Topical


Chlorhexidine and chlorhexidine digluconate are used as general disinfectants for cleansing wounds,

skin, instruments and equipment. They are also used as teat dips and sprays for an aid in the control

of mastitis in dairy cattle.


Chlorhexidine is poorly absorbed after topical application. Following use as an antiseptic treatment of

wounds or skin, residues in tissue would be expected to be insignificant. The use of chlorhexidine as

a teat dip or spray in dairy animals usually occurs following milking; residues are unlikely to occur inmilk from the following milking.


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Residues of chlorhexidine are unlikely to occur in consumed milk or animal products. In addition

chlorhexidine is poorly absorbed orally through the gastrointestinal tract with the majority of residues

passing unchanged into the faeces. Given the low reported toxicity of chlorhexidine it would not be

expected to result in any dietary risk.


Chlorhexidine has a long recorded history of safe use in human medicine for topical antiseptic and

disinfectant use and within oral preparations such as lozenges and dental gels. Human volunteers

have been reported to easily tolerate levels of 2000mg orally administered chlorhexidine per day for 7

days. Given that residues are unlikely to occur following the use of chlorhexidine as a veterinary

medicine there is no risk to the public through the proposed MRL exemption.



European Union

Chlorhexidine All food producing species Exempt for topical use only


Phytosanitary Measures the proposed MRL exemption will be notified to the World Trade

Organization. Any country may choose to comment if they believe the proposed MRL exemption

represents a barrier to their trade.

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